More Info on New PD Drug

AbbVie Announces U.S. FDA Approval of DUOPA™ (carbidopa and levodopa) Enteral Suspension for the Treatment of Motor Fluctuations in Patients with Advanced Parkinson’s Disease

· DUOPA is the first and only treatment providing 16 continuous hours of carbidopa and levodopa for motor fluctuations in advanced Parkinson’s disease

· In a clinical trial, patients treated with DUOPA experienced significantly greater improvement in “off” time than patients treated with oral carbidopa-levodopa immediate release tablets

NORTH CHICAGO, Ill. January 12, 2015 – The U.S. Food and Drug Administration (FDA) has approved AbbVie’s (NYSE: ABBV) DUOPA™ (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson’s disease. DUOPA is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube.

DUOPA was approved by the FDA as an orphan drug, a designation granted to products intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the U.S.

“There is unmet need for treatment options for patients with advanced Parkinson’s disease. As the disease advances, it can be difficult to control motor features,” said C. Warren Olanow, M.D., Professor, Department of Neurology and Department of Neuroscience, Mount Sinai School of Medicine, and lead investigator of the DUOPA pivotal trial. “In clinical trials, DUOPA was shown to significantly reduce the amount of off time advanced Parkinson’s disease patients experienced.”

In the advanced stages of Parkinson’s disease, patients may begin to experience “off” time, or periods of poor mobility, slowness and stiffness. Additionally, in Parkinson’s disease patients, the spontaneous emptying of the stomach becomes delayed and unpredictable, which can affect the timing of when orally administered medicines leave the stomach and are absorbed in the small intestine. DUOPA provides patients with the same active ingredients as orally-administered carbidopa and levodopa immediate release, but is delivered in a suspension that goes directly into the small intestine via a tube placed by a percutaneous endoscopic gastrostomy procedure with jejunal extension (PEG-J). This type of administration is intended to bypass the stomach.

“The FDA approval of DUOPA is another significant milestone for AbbVie’s pipeline,” said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. “This advancement is important for patients with advanced Parkinson’s disease and their care teams, as it provides a new therapeutic option to help manage motor symptoms.”

“Due to the progressive nature of Parkinson’s disease, it can be difficult to treat over time, especially in the advanced stages,” said Joyce Oberdorf, President and CEO, National Parkinson Foundation. “Our organization is encouraged by the introduction of a new therapy that may provide another treatment option for affected patients and families.”

Good News!

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FDA Approves RYTARY for Treatment of Parkinson’s Disease

– Jan 08 2015

The Parkinson’s Disease Foundation (PDF) alerts the community that RYTARYTM, an extended release formulation of carbidopa/levodopa, has been approved by the US Food and Drug Administration (FDA) for the treatment of Parkinson’s disease. The approval was announced today by the drug’s manufacturer, Impax Pharmaceuticals.

Among the medications available to treat Parkinson’s disease, carbidopa/levodopa, often taken as Sinemet(R), remains the gold-standard for easing motor symptoms. But as Parkinson’s disease advances, the drug becomes effective for shorter time periods. This often makes it necessary for people with Parkinson’s disease to take the carbidopa/levodopa four or more times a day to control symptoms.

Even then, people with PD taking the drug experience drops in their levels of levodopa, causing a worsening of motor symptoms as the drug “wears off.”

In recent years, drug manufacturers have tried to develop a formulation of carbidopa/levodopa that would release more slowly over time, and keep levodopa levels more even, thus reducing “off times” for people with Parkinson’s disease. The manufacturer of RYTARYTM states that the drug is designed to reduce off times in people with Parkinson’s disease.

“A new drug for PD is always a cause for celebration. RYTARYTM is formulated to kick in rapidly, then maintain blood levels longer than immediate-release carbidopa/levodopa,” says Kathleen M. Shannon, M.D., Chair of PDF’s Medical Policy Committee and Professor of Neurology at the PDF Research Center at Rush University Medical Center. “This makes it potentially useful for people with Parkinson’s who are having wearing off of drug benefit between doses.”

The manufacturer has announced its expectation for the drug to be available in February 2015 in four strengths. The dose of RYTARYTM must be adjusted carefully as there is not a simple 1:1 relationship between the dose of carbidopa/levodopa and that of RYTARYTM. People with Parkinson’s disease who are interested in RYTARYTM are advised to discuss with their doctors the potential risks and benefits of the drug in comparison with other PD drugs.

PDF welcomes the addition of this new tool for clinicians and people with Parkinson’s disease. For additional information about medications for Parkinson’s disease, please contact PDF’s HelpLine at (800) 457-6676 or info@pdf.org or use our free resources below.

Download Fact Sheet: Understand PD Medications

View PD ExpertBriefing: Medication Side Effects

View PD ExpertBriefing: Managing the Motor Symptoms of PD

Friday’s Funnies, Facts, and other Frivolous Findings

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Okay, before watching all the holiday TV shows and movies so you  can hang Christmas lights, did you know that the best predictor of weight regain is frequent television viewing and that more than 500,000 Americans are injured and 300 die each year while using ladders? Keep in mind the 4-and-1 rule; for every 4 feet the ladder rises up the wall, the base of the ladder should extend 1 foot from the wall.  Be careful.

PD patients: did you note the cognitive function and depression and muscle protein synthesis aspects of Vitamin E? Ask your doctor if supplements might be beneficial to your drug therapy.

 

For all those people who know there’s something wrong with their cars but have no clue what the problem is or how much it’ll cost to fix, here’s a chart from a mechanic’s garage, along with prices:
Ping, Click, Ping-   $10
Click, Whir, Click – $30
Clunk, Whir, Lunk -$50
Thud, Clunk, Thud –  $100
Clang, Thud, Clang – $200
I Can’t Describe It –  $500

When Restlessness Keeps You Up at Night

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When the Little Monster (aka Parkinson’s disease) began making its debut into my life in undeniable ways, one of the symptoms was RLS, otherwise known as Restless Leg Syndrome. RLS is a condition that can manifest itself in others who don’t necessarily have Parkinson’s and yet, it doesn’t matter whether you have PD and RLS together or not – either way it is quite annoying.

RLS makes your legs feel tingly and jumpy – restless, like its name, to say the least. You feel like your nerves are going to jump right out of your lower limbs and I have found myself in the wee hours of the morning, walking in circles to get it to stop.

RLS has lead me to find comfort in Psalm 37, where David talks about being patient and trusting the Lord. When we grow restless and are not necessarily putting our trust in God, we tend to take matters into our own hands and try to fix what is wrong in our lives by ourselves. But David found a better way. He trusted God and in doing so, he found rest – the opposite of being restless.

David had learned to dwell where he was and enjoy God in that place. He was able to delight in the Lord because his focus was vertical, not horizontal. It took patience – being still and waiting on God. Virtues that are quite opposite from that of being restless.

The remedy from restlessness in the spiritual realm is trusting. Trusting in a God who promises to give us the desires of our heart when we find delight in Him. When God makes a promise, such as providing for you, protecting you, forgiving you, loving you, or maybe giving you the desires of your heart, you can trust Him and not spend the night hours pacing the floor in anxiousness and restlessness.

Are you restless about something and haven’t trusted God to come through? Give it over to Him now and claim Psalm 37 and then… wait patiently for Him to do it.

Trust in the Lord and do good; dwell in the land and enjoy safe pasture. Delight yourself in the Lord and he will give you the desires of your heart. Commit your way to the Lord; trust in him and he will do this: He will make your righteousness shine like the dawn, the justice of your cause like the noonday sun. Be still before the Lord and wait patiently for him. Psalm 37:3-7a NIV